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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 840
Medical Device Problem Code Power Problem (3010)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer.The initial regulatory report was submitted under retrospective summary report e2017032.Per review of complaint on (b)(6) 2018, additional information/corrections needed to be provided.Repair summary: a service engineer (se) troubleshot the issue with the customer over the phone to resolve the reported issue.The se sent a power supply assembly for the customer to replace.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during servicing, the 840 ventilator had a power supply issue.The ventilator was not in use on a patient at the time of the event.
 
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Brand Name
840 VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
COVIDIEN
micheal collins rd mervue
galway
MDR Report Key7470675
Report Number8020893-2018-00197
Device Sequence Number13479301
Product Code CBK
UDI-Device Identifier10884521076983
UDI-Public10884521076983
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K151252
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,o
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number840
Device Catalogue Number4-840220AIQC-FR
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/12/2018
Initial Report FDA Received Date04/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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